- First Patient in for Phase II Study of FX06 in Patients With Myocardial Infarction (the F.I.R.E. Study)

Fibrex Medical Inc., a biopharmaceutical company focusing on cardiovascular and inflammatory diseases, today announced that its subsidiary Fibrex Medical Research & Development GmbH has initiated a Phase II clinical trial of FX06 to target reperfusion injury - the damage to heart muscle that results from remedial treatment following a heart attack. FX06 acts by preventing the inflammatory response, when blood flow is restored. It is this inflammatory response that results in much of the damage to heart muscle following Acute Myocardial Infarction (AMI).

The trial, which is to be called the F.I.R.E (FX06 In REperfusion) study, will be a double-blind placebo-controlled study involving 140 patients at 20 leading centres of interventional cardiology in nine European countries. The primary endpoint is myocardial salvage (tissue saved from necrosis) at five days post percutaneous coronary intervention. FX06 will be administered to patients that have just suffered from AMI and the effect on heart muscle preservation during reperfusion will then be assessed using the most advanced imaging technologies from nuclear medicine (Tc99m single photon emission tomography (SPECT) and magnetic resonance imaging (CMR) FX06 through its potent inhibition of leukocyte transmigration is expected to prevent reperfusion injury and reduce infarct size. The F.I.R.E. study aims to clinically demonstrate this activity.

"We are excited to achieve this important milestone for Fibrex Medical" stated Rainer Henning, President and CEO of Fibrex Medical. "FX06 is a first in class product with the potential to provide clinical benefit to the huge number of patients who survive their heart attack, but experience deteriorating health later in life, because the damage to their heart muscle was greater than it should have been."

"Prevention of reperfusion injury is the last frontier in interventional cardiology", said Dan Atar, Professor of Cardiology at the Aker University Hospital in Oslo, Norway, who is the Coordinating Investigator for the F.I.R.E. Study. "We expect that FX06 will become an important addition to the armamentarium of the cardiologist in the catheter lab."

The novel mechanism of action that Fibrex Medical has discovered to target acute inflammation also lends itself to application in other diseases involving an acute inflammatory response. Fibrex Medical is therefore exploring opportunities in hemorrhagic and septic shock, diseases with high mortality, where patients have very few treatment options.

About Fibrex Medical Inc.

Fibrex Medical Inc. is a privately held company registered in Wilmington, DE, USA with operations in Vienna, Austria. The Company is developing innovative therapeutics for acute and intensive care in cardiovascular and inflammatory conditions based on novel mechanisms of action. Fibrex Medical started operations in 2001, and has raised a $10M Series A investment from top tier venture capital investors including Atlas Venture, Global Life Science Ventures, EMBL Ventures and Mulligan Biocapital.

Notes to Editors:

Acute Myocardial Infarction (AMI) and reperfusion injury Acute Myocardial Infarction (AMI) remains to be the number one cause of death in the developed world with approximately 2.1 million new cases per year in the USA, Western Europe and Japan. Percutaneous coronary intervention to re-establish blood flow has become the standard of care for AMI patients. While rapid reperfusion is essential to preserve myocardium, the sudden exposure of the ischemic area to blood leads to an acute inflammatory reaction causing additional damage. It is now well accepted that this process termed reperfusion injury limits clinical success of the intervention.

How FX06 works

The process that leads to the sudden inflammatory response is caused by a massive influx of leucocyte subtypes responding to the reperfusion. FX06 is a peptide that potently inhibits the binding of fibrin E1 fragment to vascular endothelial (VE) cadherin. The drug has been shown to inhibit extravasation of major leukocyte subtypes by blocking transmigration through the endothelial layer, a bottleneck in the inflammatory cascade.

Results in previous trials of FX06

In a number of preclinical models of acute myocardial infarction, FX06 has been shown to reduce infarct size up to 50%. In a phase I study in healthy volunteers, FX06 was proven to be extremely well tolerated up to high doses.